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Lexiva (FOSAMPRENAVIR)
Lexiva works by blocking the protease enzyme, which is necessary for HIV to replicate.
Lexiva (FOSAMPRENavir) is a protease inhibitor, a type of antiretroviral medication. It was originally developed by ViiV Healthcare and is used to treat human immunodeficiency virus (HIV) infection. Lexiva is a small molecule that works by inhibiting the protease enzyme, which is essential for the replication of HIV. It was FDA-approved in 2003 and is now available as a generic medication. As an off-patent medication, it is no longer protected by patents.
At a glance
| Generic name | FOSAMPRENAVIR |
|---|---|
| Sponsor | GSK |
| Drug class | Protease Inhibitor |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2003 |
Mechanism of action
Fosamprenavir is an antiviral agent [see Microbiology (12.4)].
Approved indications
- Human immunodeficiency virus infection
Common side effects
- Diarrhea
- Rash
- Nausea
- Vomiting
- Headache
- ALT increased
- AST increased
- Abdominal pain
- Fatigue
- Neutropenia
- Triglycerides > 750 mg/dL
- Neutrophil count < 750 cells/mm3
Drug interactions
- CYP3A4 Substrates
- alfentanil
- bosentan
- itraconazole
- ixabepilone
- lidocaine
- lovastatin
- maraviroc
- methadone
- methylergometrine
- methysergide
- midazolam
Key clinical trials
- Fosamprenavir for Laryngopharyngeal Upper Airway Tissue Treatment and Enzyme Reduction (PHASE2)
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2,PHASE3)
- Oral Fosamprenavir + Sodium Alginate for GERD (PHASE2)
- Study Of An Investigational Regimen Including FDA Approved HIV Drugs In HIV-Infected Pediatric Subjects (PHASE2)
- Dual Versus Triple Protease Inhibitor Combinations, Including Ritonavir, in HIV Infected People (NA)
- Using Drug Levels and Drug Resistance Testing to Select Effective Anti-HIV Drug Combinations in Patients With Drug-resistant HIV (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |